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ACTIVE NOT RECRUITING
NCT05250973
PHASE2

A Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to characterize cardiac safety of Daratumumab, Cyclophosphamide, Bortezomib, and Dexamethasone (D-VCd) treatment regimens (Arm A: daratumumab + immediate VCd treatment and Arm B: daratumumab + deferred VCd) in newly diagnosed systemic amyloid light chain (AL) amyloidosis with cardiac involvement and to identify potential mitigation strategies for cardiac toxicity (cohort 1); to characterize the pharmacokinetics of subcutaneous (SC) daratumumab, among racial and ethnic minorities, including Black or African American, with newly diagnosed AL amyloidosis treated with D-VCd (cohort 2).

Official title: A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

151

Start Date

2022-03-01

Completion Date

2027-03-02

Last Updated

2026-01-16

Healthy Volunteers

No

Conditions

Interventions

DRUG

Daratumumab

Daratumumab will be administered subcutaneously.

DRUG

Cyclophosphamide

Cyclophosphamide will be administered either orally or IV.

DRUG

Bortezomib

Bortezomib will be administered by SC injection or IV.

DRUG

Dexamethasone

Dexamethasone will be administered orally or IV.

Locations (46)

City of Hope

Duarte, California, United States

Smilow Cancer Hospital/Yale Cancer Center

New Haven, Connecticut, United States

Moffitt Cancer Center

Tampa, Florida, United States

Winship Cancer Institute Emory University

Atlanta, Georgia, United States

Tufts Medical Center

Boston, Massachusetts, United States

Boston University Medical Center

Boston, Massachusetts, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Memorial Sloan Kettering

New York, New York, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Wake Forest University - Baptist Medical Center

Winston-Salem, North Carolina, United States

University Hospital of Cleveland

Cleveland, Ohio, United States

Ohio Health Research Institute

Columbus, Ohio, United States

West Penn Hospital

Pittsburgh, Pennsylvania, United States

UT Southwestern Medical Center

Dallas, Texas, United States

VCU Medical Center

Richmond, Virginia, United States

University of Washington

Seattle, Washington, United States

Tom Baker Cancer Center

Calgary, Alberta, Canada

Cross Cancer Institute

Edmonton, Alberta, Canada

University Health Network UHN Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Peking University First Hospital

Beijing, China

Peking University People's Hospital

Beijing, China

West China Hospital Si Chuan University

Chengdu, China

First affiliated Hospital of Zhejiang University

Hangzhou, China

Ruijin Hospital Shanghai Jiao Tong University

Shanghai, China

CHU de Limoges

Limoges, France

Centre hospitalier Lyon-Sud

Pierre-Bénite, France

CHU De Poitiers

Poitiers, France

CHU Rangueil

Toulouse, France

Charite Campus Benjamin Franklin

Berlin, Germany

Universitatsklinikum Essen

Essen, Germany

Universitaetsklinikum Heidelberg Medizinische Klinik V

Heidelberg, Germany

Alexandra General Hospital of Athens

Athens, Greece

Università Degli Studi Di Napoli Federico Ii

Naples, Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

DIPARTIMENTO DI BIOTECNOLOGIE CELLULARI ED EMATOLOGIA - UNIVERSITà ''LA SAPIENZA''

Roma, Italy

University Medical Center Groningen

Groningen, Netherlands

Hospital Maastricht University Medical Center

Maastricht, Netherlands

UMC Utrecht

Utrecht, Netherlands

Hosp. Univ. Germans Trias I Pujol

Badalona, Spain

Hosp Univ Vall D Hebron

Barcelona, Spain

Hosp Clinic de Barcelona

Barcelona, Spain

Clinica Univ. de Navarra

Madrid, Spain

Clinica Univ. de Navarra

Pamplona, Spain

Hosp Clinico Univ de Salamanca

Salamanca, Spain

Leicester Royal Infirmary - Haematology

Leicester, United Kingdom

University College Hospital

London, United Kingdom